A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity

What Was Tested

The trial (phase 1) is built around Cagrilintide and Semaglutide.

This study will compare two different ways of giving cagrilintide and semaglutide for treating overweight and obesity.

The medicines will either be given together in 1 injection or as 2 separate injections.

The aim of the study is to find out how the different ways of injection affect the level of the medicines in the blood.

It had three arms (groups): Part A: Cagrilintide and semaglutide in separate syringes (experimental), Part A: Cagrilintide and semaglutide combined in DV3384 device (experimental) and Part B: Cagrilintide and semaglutide combined in DV3384 device (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female of non-childbearing potential (NCBP). Aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 27.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: previous participation in trial(s) with an amylin analogue unless documented that the subject was assigned to placebo treatment. participation is defined as randomisation; any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Cagrilintide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Cagrilintide study: the participants and staff both knew the treatment.

It started in 2021-07-07 with completion listed for 2022-01-19.

It ran at 2 sites in Canada (1) and Denmark (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example PART A: Number of treatment emergent adverse events and PART B: Number of treatment emergent adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and Semaglutide in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cagrilintide compound page and the Semaglutide compound page, all human trials.